| 510(k) Number |
K854123 |
| Device Name |
MIDAS REX OPERATING ROOM VISE |
| Applicant |
| Midas Rex Pneumatic Tools, Inc. |
| 3001 Race St. |
|
Fort Worth,
TX
76111
|
|
| Applicant Contact |
FOREST BARBER |
| Correspondent |
| Midas Rex Pneumatic Tools, Inc. |
| 3001 Race St. |
|
Fort Worth,
TX
76111
|
|
| Correspondent Contact |
FOREST BARBER |
| Date Received | 10/09/1985 |
| Decision Date | 11/13/1985 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|